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The Broad PCORI Funding Announcements (PFAs) seek investigator-initiated applications for patient-centered comparative clinical effectiveness research (CER) projects aligned with our priority areas for research. This PFA covers the following four priority areas outlined in PCORI’s National Priorities for Research and Research Agenda: Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; Communication and Dissemination Research, and Improving Healthcare Systems. These broad areas encompass the patient-centered comparative CER we support.

Applications should address needs of patients, caregivers, clinicians, and other healthcare stakeholders in making personalized clinical decisions across a wide range of conditions, populations, and treatments. Please note that in general, PCORI will not cover costs for interventions that are being compared in the proposed study. There are no changes to the maximum project budget (direct costs) and maximum research project period from previous cycles.

Special Areas of Emphasis

PCORI will include three Special Areas of Emphasis (SAEs) in the Cycle 1 2021 Broad PFA. The goal of calling out these SAEs is to encourage submissions to these priority areas, not to limit submissions to these topics only.

As part of PCORI’s reauthorization in December of 2019, Congress included two new national priority areas: Maternal Mortality and Individuals with Intellectual and/or Developmental Disabilities (IDD). Starting in Cycle 3 2020, PCORI allotted up to $30M for each of these topics.

Increasing Access to and Continuity of Patient-Centered Maternal Care

PCORI invites applications for comparative effectiveness research of evidence-based, multi-level, culturally adapted interventions that address barriers in access to and continuity of optimal patient-centered maternal care. This SAE addresses interventions targeting pregnancy, postpartum, and through the 12 months after childbirth with a focus on women from populations that experience significant disparities in outcomes: African American, Native American/Alaska Native, and/or rural. Interventions may include maternal care coordination, education/training for patients/providers, and/or add-on or wrap-around services to assist clinicians and patients in eliminating these disparities. Maternal outcomes must be included. In addition, infant and/or provider outcomes may also be assessed.

Improving Care for Individuals with Intellectual and/or Developmental Disabilities Growing into Adulthood

PCORI invites applications for comparative effectiveness research of interventions to optimize healthcare transitions from childhood to adulthood and the continuation of patient-centered physical and mental health care. Interventions may include person-centered transition planning; patient, family, caregiver, and provider support during the transfer of care; and support for the continuation of general and specialty adult care. Outcomes may include physical and mental health outcomes; patient, caregiver, family, and provider satisfaction; patient and family/caregiver quality of life; adherence to care; and continuation of care.

COVID-19

PCORI invites applications for comparative effectiveness of strategies to lessen the impact of longer-term sequelae, improve access to vaccines, and mitigate the impact on those disproportionately affected by the COVID-19 pandemic. This SAE focuses on research that can inform critical choices among clinical and policy options that patients, healthcare providers, health systems, policy makers, and other stakeholders will need to make that relate to COVID-19 in a post-pandemic world. While there are not set-aside funds reserved for this topic, this remains a priority area of research for PCORI.

For all the priority areas below, the social determinants of health (SDoH), as well as disparities in COVID-19 risks and health outcomes, should be considered an important aspect of interventions and/or analyses. The priority areas are:

• Management and survivorship of post-acute COVID-19
• Impact of COVID-19 on disproportionately affected populations
• Impact of COVID-19-related social isolation and loneliness on health outcomes

Reminder: The primary institution’s Administrative Official must review, authorize, and submit the full application by 5 pm ET on May 4, 2021.